Neil Grubert’s Post

Access to 𝐚𝐟𝐟𝐨𝐫𝐝𝐚𝐛𝐥𝐞 𝐦𝐞𝐝𝐢𝐜𝐢𝐧𝐞𝐬 remains a pressing challenge across Europe. Rising costs and significant price variability hinder healthcare systems and restrict patient access to necessary treatments. The lack of cohesive legislation further complicates the situation, impacting millions of lives. As 𝐡𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐩𝐫𝐨𝐟𝐞𝐬𝐬𝐢𝐨𝐧𝐚𝐥𝐬, we must advocate for solutions such as promoting generic medicines, engaging in transparent pricing discussions, and enhancing regional collaboration. By working together, we can ensure non-discriminatory access to essential medicines for every European, fostering a healthier future for all. 🔗 𝐉𝐨𝐢𝐧 𝐭𝐡𝐞 𝐜𝐨𝐧𝐯𝐞𝐫𝐬𝐚𝐭𝐢𝐨𝐧: https://lnkd.in/gns7EtCk #affordablemedicines #healthcareaccess #genericmedicines #europeanhealthcare #pharmaceuticals #healthequity #patientcare #healthcarecollaboration #accesstomedications #euhealthcare #publichealth #pricingtransparency #legislationmatters #healthforall #medaccess #innovationinhealthcare

The upcoming European Commission pharmaceutical legislation aims to level the playing field for medicine access across Europe, but there's concern about its impact on innovation. Proposals to reduce Regulatory Data Protection (RDP) could deter investment, risking a drop in innovation and access to new medicines. A report warns that reducing RDP might cost the EU €2 billion in R&D and lose 50 pipeline products. Legislation that stifles innovation might worsen the health disparities it seeks to mend. Addressing the East-West health gap in Europe is crucial, yet complex. Local issues like economic barriers and national health funding play a significant role. For instance, Romania's National Cancer Plan has taken steps to improve healthcare for uninsured people, boosting access to cancer prevention and treatment. More legislation and regulation could be a risk for Europe, while a reform to streamline innovation through regulatory approvals might save the inefficiencies that will close the East-West gap. https://lnkd.in/ebiiTrE7 #EUHealth #PharmaceuticalLegislation #Innovation #HealthcareAccess #EuropeanUnion

🌍 Spotlight on GÖG 🌍 We are proud to have the Austrian National Public Health Institute (Gesundheit Österreich GmbH) as a key partner in the PROCURE project. 🔎 Who is GÖG? GÖG is the institution responsible for researching and planning public healthcare in Austria and acts as the national competence and funding centre for the promotion of health. GÖG has extensive knowledge about pharmaceutical systems and policies in European countries and beyond, and has been designated as WHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies. The project team has vast expertise in conducting policy-relevant research on the procurement of medicines in European countries. GÖG has led a large-scale study on best practices in the public procurement of medicines, commissioned by European Health and Digital Executive Agency (HaDEA) on behalf of the European Commission. This study mapped public procurement practices for pharmaceuticals in 32 European countries using desktop research, interviews, and quantitative data (TED), resulting in detailed country fact sheets and an assessment of the possible impacts of procurement practices. GÖG has previously led the Pharmaceutical Health Information System (PHIS), which examined procurement practices in hospitals in 27 European countries. 🚀GÖG is responsible for coordinating national efforts and contributing to the overall success of the PROCURE project. This includes: ·        Establishing a “country node” and compiling an “ID Card” for Austria, describing the national healthcare and procurement systems and practices. ·        Supporting the development of the methodology for the study on healthcare systems and procurement practices in Europe. ·        Participating in the Delphi process to identify key elements for successful public procurement practices in the healthcare sector. Experts from GÖG, alongside additional experts from Austria, will bring in their views on potential improvements in current procurement mechanisms. ·        Participating in working groups to develop recommendations, ensuring they reflect the Austrian context. ·        Contributing to conferences, including the final conference, and disseminating information through GÖG’s own networks. As a public health institute focusing on research on pharmaceutical policies and systems, the staff at GÖG brings in a ‘policy view’ and analyses how procurement practices may interact with other characteristics of the healthcare system. GÖG aims to leverage insights from PROCURE to contribute to more effective and resilient healthcare procurement practices. Stay tuned to learn more about the other partners in the consortium and their roles in the PROCURE project, making healthcare procurement more resilient and efficient across the European Union! #EU4Health #EUfunded #HealthUnion #HealthcareInnovation #HealthUnion #procureproject #PublicProcurement #ActiveAgeing #EUProjects

Strong interview in the Sunday Times this morning https://lnkd.in/e_TJxXRM from Christopher Stokes Eli Lilly and Company raising the question of how NICE assesses the value of medicines and the need to consider wider societal and economic costs and benefits.   This comes on the back of a number of articles recently that highlight other challenges in getting innovative medicines to patients in the UK, whether last week's story on the application of NICE's severity modifier https://lnkd.in/ebu_E5A4 Or the analysis we did The Association of the British Pharmaceutical Industry (ABPI)@ABPI_UK showing how even when NICE recommends a medicines, adoption in the NHS is often very challenging. https://lnkd.in/e-ASB2Qs How medicines are priced, how much the NHS spends and how that spend is managed is often an emotive topic. No one wants to feel that the NHS is spending too much. At the time same time, it's clear that new medicines and vaccines simply wouldn't exist if the private sector wasn't able to maintain the extraordinary level of high-risk investment (now over $300bn) that is necessary to discover and develop treatments.   Perceptions of what's actually happening with medicines spend often diverge from reality. Many will assume that spend on branded medicines is a significant driver of NHS cost. But figures often presented ignore billions of pounds of rebates paid back to the government by companies. Once these rebates are taken into account it's clear that NET branded medicines spend as DECLINED in real terms over the last decade. This decline in investment has left the NHS spending a smaller share of overall healthcare cost on medicines that any comparable economy (see chart below).   I think Rt. Hon. Wes Streeting MP is spot-on in identifying three strategic shifts that are necessary to fix the broken NHS, from: - hospital to community - analogue to digital - treatment to prevention.   Medicines and vaccines have a vital role in all three of these priorities but we are not currently realising the potential. A decade of declining investment has left us with patchy adoption and real tensions on price due to the UK being so far out of line with most of the developed world.   The pharmaceutical industry has a strong tradition in the UK of partnering with the government to try and grow the sector whilst also managing cost. The most recent Voluntary Scheme for Medicines Pricing Access and Growth is an attempt - albeit in challenging economic times - to lay the foundations of a move back to international competitiveness. Looking to the longer term, though, we need to be much more ambitious. Declining investment in new medicines is part of the 'broken NHS', and if we're serious about fixing it, we need to reverse that trend.  

Thought-provoking stuff from Richard Torbett MBE and Christopher Stokes. The absence of wider economic and societal benefits within the UK's HTA framework feels increasingly problematic, in an era in which the UK's health issues are now a visible drag on the economy - as John Burns-Murdoch's Financial Times analysis has revealed so powerfully, e.g. https://lnkd.in/ep8xYd8V That context is reflected by Rt. Hon. Wes Streeting MP's direction to the DHSC that it adopt the role of an economic department, and this surely makes sense. NICE has often led the world in developing and applying HTA; this seems the natural and necessary next step. Industry cannot assume that such a move will always help its cause. In principle wider societal/economic benefits should be accounted for in funding decisions for all technologies, and non-technological interventions. That means that - as the NHS wrestles with how to prioritise its funding - an evolution to better reflect such aspects might not prove a positive move for technologies whose profile is weak in these respects. That does not mean that reform should be artificially constrained to necessarily be cost neutral, a political imposition that - as in the recent case of severity modifiers - risks undermining the vital principles that underpin HTA. The same could be said of the refusal to align discount rates with Green Book best practice - another politically-driven decision which means literally choosing not to allocate resources to where we know they are most effective. Still, there will inevitably be trade-offs for Department of Health and Social Care and NHS England to manage, if we are - as we surely must - to move at pace to take up those technologies with the promise to help get Britain's economy moving. Some of this can be managed through case by case arrangements with companies - territory in which Negotient has direct experience - but others will require system change. This is a debate whose time has come.

The upcoming European Commission pharmaceutical legislation aims to level the playing field for medicine access across Europe, but there's concern about its impact on innovation. Proposals to reduce Regulatory Data Protection (RDP) could deter investment, risking a drop in innovation and access to new medicines. A report warns that reducing RDP might cost the EU €2 billion in R&D and lose 50 pipeline products. Legislation that stifles innovation might worsen the health disparities it seeks to mend. Addressing the East-West health gap in Europe is crucial, yet complex. Local issues like economic barriers and national health funding play a significant role. For instance, Romania's National Cancer Plan has taken steps to improve healthcare for uninsured people, boosting access to cancer prevention and treatment. More legislation and regulation could be a risk for Europe, while a reform to streamline innovation through regulatory approvals might save the inefficiencies that will close the East-West gap. https://lnkd.in/ed38yUh5 #EUHealth #PharmaceuticalLegislation #Innovation #HealthcareAccess #EuropeanUnion

The root causes of unavailability and delay in access of innovative medicines The speed of innovation in recent years and the promise of the industry pipeline provide an opportunity to improve outcomes for patients. However, a significant number of medicines are not available across all EU markets. There are patient access inequities within Europe, with significant differences across countries in the number of products available and the time taken prior to national reimbursement. The average time of reimbursement for innovative treatments across EU and European Economic Area has reached 531 days, ranging from 126 days in Germany to 990 days in Turkey. In the EU, once a new treatment has gone through a process of R&D lasting ten years on average, 3 further milestones must be reached before patients have access to it: 1. A European marketing authorization, confirming the quality, safety, and efficacy of the therapy 2. National authorities must secure reimbursement 3. Once reimbursed, innovations need to reach the right patients. The root causes of delays and unavailability of drugs are multifactorial: 1. The speed of the regulatory process 2. Accessibility of medicines before marketing authorization 3. Initiation of the pricing & reimbursement process 4. The speed of national timelines and adherence 5. The value assessment process 6. The right product differentiation 7. Health system constraints and resources (budget) 8. Diagnosis, supporting infrastructure and relevance to patients 9. Multilayer decision-making process. These may be solved only by stakeholders working together. Here´s a series of specific proposals to improve patient access to innovative medicines and reduce inequalities across Europe: • A commitment from the industry to file pricing and reimbursement (P&R) applications no later than 2 years after EU market authorization • The creation of a portal where marketing authorization holders can provide timely information on the timing and processing of P&R applications • A conceptual framework for equity-based tiered pricing (EBTP) to ensure that ability to pay across countries is considered in the prices of innovative medicines, anchored in a principle of solidarity • Novel payment and pricing models that can accelerate patient access • An efficient implementation of Health Technology Assessment (HTA) across Europe. Comparative research of the time length from application to granting of marketing authorization has shown that the European regulatory process is slower than some international processes, particularly that of the US. The approval timelines have generally converged in other regions of the world, whereas times in Europe have remained relatively unchanged. Hence, Europe is lagging. #Pharma #Marketaccess #Marketingauthorization #Pricing #Reimbursement Visit us on https://lnkd.in/d5tuZczF or look for more information on https://lnkd.in/dytEHHne

💡 New! The NHS expenditure on pharmaceuticals, especially in hospital settings, has outpaced the expenditure on other healthcare services. There is a question on whether this allocation of money is the most efficient in terms of saving lives. Huseyin Naci, Peter Murphy, Beth Woods, James Lomas, Jinru Wei and Irene Papanicolas argue that the way the National Institute for Health and Care Excellence (NICE) calculates the cost-benefit analysis for new drugs should be more transparent, taking into consideration those who will lose out due to reduced resources for other treatments. https://lnkd.in/dS8P8Zhw

This is a very important post from Richard Torbett MBE at The Association of the British Pharmaceutical Industry (ABPI) It shows the UK spending significantly lower on medicine than peer countries, which is something that every pharmaceutical company knows. Looking at it from NHS point of inevitably requires taking apart quantity and price - and there are important issues to address in both. The quantity of use of NICE recommended medicines per capita is what would like to see and understand. Our recent report showed that there is significant variation within the UK in this. And there is lots of evidence to show that gaps in presentation, diagnosis, treatment and adherence vary widely across the UK especially by level of income and wider determinants measured in IMD. The consequence can be measured in lost lives in the key killers including cardiovascular, cancer and dementia which CF and IPPR published on 5 years ago. Economically this gap can be measured in lost economic growth due to productive years of life, worklessness of long term sick and productivity. The price of medicines paid is something that NHS England generally looks at as something to be proud of the large confidential discounts extracted from companies. But there is reason to be concerned that the level of pricing has meant that Pharma companies bypass the UK in launching new therapies and investing in manufacturing and R&D. Indeed we published on this with IPPR 5 years ago and pointed to a £10b gap per year that the UK share of R&D and manufacturing had lost. The risk is the savings on medicines discount is wind up being greater than the lost economic growth. If to pick up the words of Dave Ricks that if a country were to consider how it could enable the rapid uptake of medicine within guidelines but use data and digital to support this and support behavioural change that would be pretty attractive. So the way an economist running the country ought to look at it is to look at maximising the net value of medicine and life sciences industry 1. Maximise the uptake of medicine within recommended guidelines as these have been triple approved (By MHRA, NICE and NHS) to maximise health gain, minimise healthcare cost and maximise the economic contribution 2. Maximise value of the life sciences in R&D, manufacturing and jobs in the UK, including the value of using data digital and AI to support 3. Compare this to the net cost of medicine This is doable as an approach but it is not being done due to unresolved competing objectives

EFPIA urge Member State representatives to take into account concerns over the workability of the EU HTA - “Europe cannot miss out on the opportunity to speed up access to innovative medicines for European patients”. Whilst EFPIA welcome the Regulation (EU) 2021/2282 they believe the draft rules in its current format create an “unworkable framework” for Joint Clinical Assessments (JCAs) and “consequently lead to duplication of work”. The draft Implementing Act has recently been published for public consultation, this will document the step-by-step process and timelines of the JCA procedure. EFPIA criticise the procedure not involving manufacturers responsible for submission to the JCA, unless in exceptional cases. In addition, EFPIA suggest the timelines with the current framework are unworkable and too short for companies to provide the input required throughout the JCA. EFPIA go on to mention the lack of transparency, predictability, and workability as further reasons as to why the workability of the process is in doubt. A challenge EFPIA identify is surrounding the scoping phase. They mention that Member States have a 140 day period to develop the scope, with no involvement from companies responsible for the submission. After this closed scoping phase companies then only have 90 days to respond to the PICOs identified by Member States that form the scope. Such timelines EFPIA claim could lead to companies delaying regulatory procedures (clock stopping) in order to satisfy the strict requirements of the JCA timelines. EFPIA also call on the need to include a step to allow companies to have a possibility of early interaction and input into the definition of the scope, allowing the anticipation of PICOs well in advance of the 90 day clock start process and potentially increasing the quality of the overall submission. James Whitehouse, Joint Managing Director at Lightning Health said, “Lightning Health agree that for the procedure to work it must have the involvement of all stakeholders throughout the process. All companies, no matter their size, will face tremendous challenges with resourcing both regulatory and access timelines in parallel, whilst then facing the next hurdle of Member State technology assessments leveraging the initial JCA outcome. Without transparency and leveraging of expertise at every step, it could hinder, rather than help, patient access. Having identified this challenge early on we are working tirelessly to support companies in anticipating the likely PICO scenarios in a safe environment through PICOScan™ as well as supporting what is an incredible initiative to build equitable access to healthcare across Europe and minimise duplication for Member States at a national level.” https://lnkd.in/ebtaKBrM